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临床试验/NCT06554314
NCT06554314招募中不适用

Effect of Probiotics on Regulating Gut Health and Blood Lipid in Overweight and Obese Adults

Chung Shan Medical University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年5月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Change from baseline serum lipids at week 4

研究概览

简要总结

The purpose of this study was to evaluate the efficacy of 1 capsules (300 mg per capsule) of Nutrarex Probiotic Capsules per day in regulating gut health and blood lipid in adults by clinical trial.

详细描述

This experiment is carried out in a controlled manner. Before the subjects enter the research experiment, they need to follow their original lifestyle. The habits of maintaining a constant body weight for more than 2 weeks before the test, such as calorie balance in the diet and the amount of activity. Then enter the test to carry out the evaluation test of probiotics to the end. 50 subjects were randomized, 25 to placebo and 25 to probiotics. The subjects took one capsules of Nutrarex probiotics daily, a total of 300 mg. Continue to take it for 4 weeks, and perform blood routine tests. Body composition detection, waist and hip circumference measurement, related index analysis and 24-hour dietary questionnaires, gut health questionnaires and stool samples were collected and analyzed for 4 weeks before and after treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • male or female participants
  • aged 20-65 years old
  • body mass index in 25-27 kg/m2 or body fat > 25% for men and > 30% for women

排除标准

  • cancer, chronic heart disease, use drugs which pharmacological effects may affect immunity having systemic infections
  • using probiotics.

结局指标

主要结局

Change from baseline serum lipids at week 4

时间窗: Week0, Week4

Compared the difference of serum lipids level between the week 4 and 0

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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